Senate report: GSK diabetes drug poses heart attack risk; draws response from drug maker

RESEARCH TRIANGLE PARK, N.C. A report released over the weekend by a Senate committee linked a drug used to treat diabetes to heart attacks, prompting a denial by the drug’s manufacturer.

The Senate Committee on Finance, of which Sen. Max Baucus, D-Mont., serves as chairman and Sen. Chuck Grassley, R-Iowa, is ranking member, released the report Saturday, alleging that GlaxoSmithKline knew of heart attack risks in patients taking the diabetes drug Avandia (rosiglitazone) “several years prior” to the May 2007 publication of a study showing the link in the New England Journal of Medicine. The report was based on a two-year investigation that followed the report and included reviews of more than 250,000 documents and contacts with GSK, the Food and Drug Administration and anonymous whistleblowers.

“As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” the report read. “Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

GSK denied the Senate committee report’s allegations. The British drug maker said in a statement Saturday that the report was based on analyses “not consistent with the rigorous scientific evidence supporting the safety of the drug” and that it cherry-picked information from documents to mischaracterize GSK’s research efforts.

Also on Saturday, the company singled out for criticism The New York Times, which had reported the day before on confidential FDA documents from 2007 in which agency scientists had recommended Avandia’s withdrawal from the market, reporting also that the drug was linked to 304 deaths during third quarter 2009. But GSK said in its response that the FDA had since examined the available evidence, including the scientist’s assertions, and recommended that Avandia remain available.

“Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,” GSK said in the statement.